Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced the initiation of a Phase 2 study evaluating ISIS-FXIRx in patients with end-stage renal disease (ESRD) on hemodialysis. In May 2015, Isis entered into an exclusive license agreement with Bayer HealthCare (Bayer) to develop and commercialize ISIS-FXIRx for the prevention of clotting disorders. The Phase 2 study is intended to further characterize the profile of ISIS-FXIRx and will provide essential data for Bayer's future clinical development program for ISIS-FXIRx. Upon completion of the study and advancement of the program by Bayer, Isis will be eligible to receive a $55 million payment.
"ESRD patients receiving chronic dialysis are prone to increased thrombosis. However, antithrombotic treatment options for these patients remain limited because these patients also have a high risk of bleeding. ISIS-FXIRx is a first-in-class antisense drug in clinical development that has shown a significant reduction in clotting without increasing bleeding events in previous clinical studies. This Phase 2 study furthers both our and Bayer's goal of initially providing ISIS-FXIRx to patients with high unmet need," said B. Lynne Parshall, chief operating officer at Isis Pharmaceuticals. "These data will support Bayer's plans for a robust development program to optimize the clinical potential of this drug."
ISIS-FXIRx is designed to inhibit the production of Factor XI, a coagulation factor produced in the liver that is involved in the propagation of clots. The Phase 2 study is a randomized, double-blind, placebo controlled study in which ISIS-FXIRx will be administered to approximately 50 patients with ESRD on hemodialysis. The first patient has already been dosed in this study that will evaluate the safety, pharmacokinetic and pharmacodynamic effects of weekly dosing of 200mg or 300mg ISIS-FXIRx for up to 12 weeks.
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